Our Services

Our Services

esqLABS develops and utilizes OPEN-SOURCE software to create physiologically-based Quantitative Systems Pharmacology (PB-QSP) platforms as value-generating, holistic Modeling & Simulation solutions to support our customers’ decision making process along the entire life cycle of pharmaceutical products from research through development and at the point of care.

PB-QSP Platform Development

Today, in silico studies and trial simulations already complement experimental approaches in pharmaceutical R&D. However, project workflows and current software tools usually focus on isolated aspects of drug action, such as either pharmacokinetics at the organism scale or pharmacodynamic interaction (i.e. systems-biology) on the molecular level, even though biology is always multiscale by nature.

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… within one single platform

The multi-scale physiologically-based (PB) modeling concept [1] in our PBPK models and PB-QSP platforms make it possible to integrate…

  • multi-scale data from all biological scales (in-vitro, preclinical, individual and population-level clinical data)
  • drug, disease, and physiology knowledge across multiple treatments within a therapeutic area

Through modeling & simulation, the multi-scale PB framework is then leveraged in pharma R&D and care for … 

  • consistent and quality-controlled build-up and transfer of actionable knowledge
  • informed decision-support across all phases of drug research & development, and care

Our sophisticated model of glucose homeostasis …

… offers a powerful platform for research, drug development, and treatment personalization in the indication of Diabetes and metabolic diseases. The PB-QSP approach covers various scales from hormone-receptor interaction to population variability within different species. The backbone of our platform is open-source and under continuous development

Features

  • Full PBPK representation of clinical biomarkers and treatments
    • Glucose & HbA1c, multiple Insulins, Glucagon, GLP1, GIP, SGLT2 Inhibitors …
  • … coupled with relevant PD mechanisms down to the insulin receptor level [2]
  • Relevant preclinical species: rat, monkey & minipig [3]
  • In-silico patient representations: healthy, T1DM,  T2DM
  • PK-modules: FcRn-binding, protein-Albumin binding, subcutaneous drug- and oral glucose- and meal absorption [2,4]

Informed & Validated

  • With data from clinical trials, literature & partners [2,5,6]
  • Tested in clinical trials within a closed-loop artificial pancreas system [5,6]
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Efficiently leverage your preclinical experiments

  • Physiologically-based  framework to maximize learnings from animal experiments …
  • … and translation to humans for a more efficient use of animal experiments

Assess in-licensing options and new drug derivatives

  • Asses the effect of e.g. Fc-Fusion- or Albumin-binding approaches on compound PK & PD
  • Assess potential benefit of drug combinations or multi-agonist entities
  • Assess the optimal dose ratio for combination therapies

Clinical Trial Simulations

  • Optimize trial design to ensure successful outcome (cohort selection, titration rules, measurement intervals and  clinical endpoints)
  • Assess treatment benefit in different populations (T1DM vs. T2DM) 
  • Benchmark precandidates vs. competitors for an optimized marketing strategy
  • Optimize your medical device strategy by assessing effects of device properties on product & treatment efficacy

WITHIN A PROFESSIONAL, QUALITY-CONTROLLED PBPK/PD MODELING & SIMULATION FRAMEWORK [1]

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List of Publicatons
  1. Eissing T, et al.: A computational systems biology software platform for multiscale modeling and simulation: Integrating whole-body physiology, disease biology, and molecular reaction networks. Front Physio 2011
  2. Schaller S, et al.: A generic integrated physiologically-based whole-body model of the glucose-insulin-glucagon regulatory system. CPT: PSP 2013
  3. Schaller S, Klabunde T: Towards Predictions of Clinical Trial Outcomes: Combining PBPK and QSP within a Translational Diabetes Disease Platform, PAGE Meeting 2018, Montreux
  4. Niederalt C, et al.: A generic whole body physiologically based pharmacokinetic model for therapeutic proteins in PK-Sim. J Pharmacokinet. Pharmacodyn. 2018
  5. Schaller S, et al.: Robust MPC of blood glucose using generic whole-body physiology-based PK/PD model kernels. IEEE Transactions in Biomedical Engineering 2015.
  6. Schaller S: Automated Optimal Glycaemic Control using a Physiology-Based Pharmacokinetic/Pharmacodynamic Model. [PhD Thesis]: RWTH Aachen University 2014.

PBPK Consulting

In addition to PB-QSP platform development esqLABS also provides services & consulting for standard applications of PBPK models using the Open-Systems-Pharmacology Suite with PK-Sim® and MoBi®.

Services are:

  • Preclinical/clinical base PBPK model development
  • Special populations: PBPK-based pediatric investigations and organ impairment studies
  • DDI Investigations
  • Translational modeling for first-in-man dose predictions
  • … and more. Contact us for details …

Trainings & Workshops

esqLABS provides individual trainings for customers on PBPK and PB-QSP modeling and simulation with PK-Sim® and MoBi®, taylored to your needs, starting at your level and bringing you to the edge in this field.

On a regular basis, we conduct workshops on how to best utilize PK-Sim® and MoBi® for your model-based drug development strategy. Topics span from applications for

  • ADME and DMPK characterization: Preclinical/clinical base PBPK model development, PBPK-based pediatric extrapolation, Special Populations, DDI Investigations, translational modeling for first-in-man dose predictions …
  • To utilizing the power of a physiologically-based framework for therapeutic-area specific questions related to disease physiology:  combining PBPK and QSP approaches for quantitative analysis of mechanisms underlying a disease and its treatment.

A list of future events can be found in our News & Events section.

Get in touch now

Contact

esqLABS GmbH | Hambierich 34 | 26683 Saterland | Germany
Tel. +49 151 / 58559070 | info@esqLABS.com